Food

• Food Facility (Manufacturer, Processor, Packer, Labeler, Repacker, Relabeler, Holder) and Importer Registration with FDA, Food Labeling
• Low Acid or Acidified Food Manufacturer / Product Registration with FDA
• Food Auditing Coordination

Dietary (Herbal) Supplement

• Dietary Supplement and Chinese Herbal Medicine Manufacturer and Product Registration with FDA
• Chinese Medicine Ingredient Screening, Filtering and Labeling

Fruit, Vegetable, Plant, Seed, Animal Byproduct

• Fruit, Vegetable, Plant, Seed, Endangered Species and Animal Byproduct Permit Application with USDA, FWS and EPA

Food Contact Substance (FCS)

• FCS Notification for New Use

Seafood Permit

• NOAA Seafood Permit

Medical Device

• Medical Device Class I, II, III Manufacturer and Medical Device Listing with FDA, 510K Premarket Notification Submission
• Medical Device UDI Account Setup and GUDID Buildup
• NIOSH (CDC Approval for N95 Face Mask) Application
• MDF Filing (eCTD)
• MDSAP (Voluntary Medical Device Single Audit Program)
• Medical Device Auditing Coordination

OTC NDC

• OTC Drug NDC (National Drug Code) Application with FDA including Special Cosmetics with Drug Claim

Cosmetics

• General Cosmetic Ingredient Screening and Voluntary Ingredient Statement Filing (VCRP) with FDA
• Tattoo & Permanent Makeup
• Disposable Wipes
• Aromatherapy
• Hair & Nail Products
• Soaps & Lotions
• Tanning Products

E-Cigarette

• E-Cigarette Import and Manufacturer Listing with FDA, Premarket Review Submission

Consumer Necessities

• CPSC-Regulated Industries – Consumer Product Safety Commission on safety of products such as Disinfectant (Wipes and Spray), Health Mattress and Paint

Fertilizer

• Fertilizer Import Arrangement with USDA and/or EPA

CBD /Hemp Seed, Oil

• CBD (Hemp Seed and Oil) Import Engagement

Alcoholic Beverage License

• Alcohol Import & Export Distribution and Domestic Wholesale/Retail License

Customs Entry and Detention

• Negotiation and Settlement with U.S. Customs pertaining to patent, trademark, copyright infringement and unlawful, illegal customs handling.

FDA Detention

• Negotiation and Settlement with FDA on Detained Import Entries
• FDA Form 483, Warning Letter and Red List Rectification
• Removal from Import Alert and Red List
• ITACS, ESG, GUDID Submission Gateway

Permit

• Other Government Agencies’ Permits and License Application Filing

Compliance Plan Drafting

• FSVP Plan Comprising and Implementing
• HACCP Plan Comprising and Implementing
• SOP Comprising and Implementing
• SSOP Comprising and Implementing
• Drug Quality Agreement Comprising and Implementing
• Medical Device Reporting (MDR) Implementing and Customer Complaint Handling

Lab Test Coordination

• FDA Recognized lab arrangement
• Heavy Metal Test Report Interpretation
• Microorganism Test Report Interpretation
• Pesticide (Chemical Residue)
• Test Report Interpretation

Plant Visit and Regulatory Violation Rectification

• FDA-regulated Facility GMP Compliance and Corrective Action

U.S. Trademark and Patent

• U.S Trademark Filing & Patent Referral

Board of Pharmacy License

• California Board of Pharmacy Wholesale License Application Filing

California Department of Public Health

• Food Plant Manufacture / Process License Issuance

Organic Cert, NFS, Kosher, HALAL, RoHS, UL, ETL, UPC Code

• Organic Food Cert, NFS, Kosher, HALAL, RoHS, UL, ETL, UPC Code Filing
• ISO 13485 Training Engagement

Product Manual & Brochure in English

• Product User’s Manual and Brochure Composition in English

Business & Product Naming

• Business and Product English Naming

Contact us at (626)234-9468, or dhue@ucs.la